PTSD
Conditions
Brief summary
The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.
Detailed description
The crossover study consists of two treatment periods of 15 days duration. On Day -1 or Day 1 of Treatment Period 1, eligible participants will be randomized (1:1) to a sequence of treatments (either Lu AG06466-placebo or placebo-Lu AG06466) with 15 participants are planned per sequence. Each treatment period will be separated by a washout period of ≥7 and ≤14 days.
Interventions
DRUGLu AG06466
Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
DRUGPlacebo
Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* The participant has PTSD, diagnosed according to Diagnostic and Statistical Manual Diploma in Social Medicine-5 (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI). * The participant has a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥28 at screening and baseline. * The participant has alterations in arousal and reactivity, confirmed on CAPS-5. * The participant has ongoing sleep disturbances, confirmed on CAPS-5. * The participant is willing to discontinue all prohibited medications during the study and to complete a washout of psychotropic medication during the washout period. * The participant does not have any magnetic resonance imaging (MRI) contraindications.
Exclusion criteria
* The index traumatic event that led to development of PTSD took place \>15 years or \<6 months before screening. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition Task | Day 15 | fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Facial Affect Recognition Task |
| Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Threat Processing Task | Day 15 | fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Threat Processing Task |
| Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task | Day 15 | fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Card Guessing Task |
| Skin Conductance Response (SCR) During fMRI Tasks | Day 15 | SCR in micro-Siemens |
| Skin Conductance Response (SCR) During the Threat Processing Task | Day 14 | SCR in micro-Siemens |
| Behavioural Measures During fMRI Tasks | Day 15 | Behavioural Response: behavioural measures rated on a 3-point scale |
| Behavioural Measures During the Threat Processing Task | Day 14 | Behavioural Response: behavioural measures rated on a 3-point scale |
| Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST) | Day 12-13 | TST in minutes |
| Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE) | Day 12-13 | SE in percent |
| Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO) | Day 12-13 | WASO in minutes |
| Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL) | Day 12-13 | SOL in minutes |
Countries
United States
Outcome results
None listed